Spots Global Cancer Trial Database for Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot
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Trial Identification
Brief Title: Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot
Official Title: Treatment of Children and Adolescents With Primary B-precursor Acute Lymphoblastic Leukemia With Combination Chemotherapy and Immunotherapy
Study ID: NCT04723342
Conditions
Interventions
Study Description
Brief Summary: THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy. QUESTIONS AND OBJECTIVES OF THE STUDY: * to determine the efficacy and feasibility of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL; * to determine the safety and toxicity of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL; * to determine the possibility of chemotherapy reducing when immunotherapy is included in the treatment regimen without loss of effectiveness; * to determine the possibility of reducing the maintenance therapy duration to 1 year when immunotherapy is included in the treatment regimen without loss of effectiveness.
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology, Moscow, , Russian Federation
National Medical Research Center of Oncology named after N.N. Blokhin, Moscow, , Russian Federation
Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University, Moscow, , Russian Federation
Almazov National Medical Research Centre, Saint Petersburg, , Russian Federation
Contact Details
Name: Alexander I. Karachunskiy, Professor,MD
Affiliation: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Role: PRINCIPAL_INVESTIGATOR
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